Oragenics, Inc. Announces U.S.-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development

Core Insights - Oragenics, Inc. has entered into a manufacturing agreement with Sterling Pharma Solutions for the GMP production of its lead drug candidate, ONP-002, aimed at treating concussion [1][2][3] - This partnership is a significant milestone for Oragenics, ensuring domestic production capabilities ahead of planned Phase IIb clinical trials expected to start next year [2][4] - The collaboration emphasizes Oragenics' commitment to quality and efficiency in developing treatments for neurological trauma, starting with concussion, which currently lacks FDA-approved pharmacological therapies [4][5] Company Overview - Oragenics, Inc. is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, with ONP-002 targeting mild traumatic brain injury (mTBI) [5] - The company's intranasal delivery technology aims to provide fast, targeted, and non-invasive therapy to the brain [5] Partner Overview - Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with over 50 years of experience in small molecule API development and manufacturing [6][7] - The company specializes in handling complex API challenges and has multiple facilities in the US and UK, employing over 1,350 people [7]